510(k) · Cleared
ClearedBIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics, LLC · PEN Gram-Negative Bacteria And Associated Resistance Markers
Cleared on Dec 20, 2024 as substantially equivalent to K193519 (Biofire Diagnostics, LLC, 2020) after a 14-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Dec 20, 2024
- Review
- 14 days
- Class
- Class II
- Product code
- PEN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K181493 (2018). No later device cites it as a predicate yet.
- Root · 2 generations backK181493 FilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC · 2018 · Recalled
- 1 generation backK193519 BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC · 2020 · Recalled
- This deviceK243759 BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147…Biofire Diagnostics, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K181493 | FilmArray Blood Culture Identification (BCID) Panel | Biofire Diagnostics, LLC | 2018 | 6 |
| −1 | K193519 | BioFire Blood Culture Identification 2 (BCID2) Panel | Biofire Diagnostics, LLC | 2020 | 7 |
| 0 (this device) | K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)… | Biofire Diagnostics, LLC | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PEN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PEN device
- #1 K262168 QIAstat-Dx BCID GN Plus AMR Panelscore 12.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K193519 | BioFire Blood Culture Identification 2 (BCID2) PanelSummary page 6…ics, LLC Introduction: The content of this Special 510(k) submission is limited to obtaining FDA clearance for the BIOFIRE Blood Culture Identification 2 (BCID2) Panel (K193519) with a software update to mitigate a risk of false negative results. According to the requirements of 21 CFR 807.92, the follow… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All PEN devicesPEN Gram-Negative Bacteria And Associated Resistance Markers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PEN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEN
Too few PEN 510(k)s in any year since 2007 to give a median.
Recalls per year · PEN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEN
13in 2025
MAUDE reports naming product code PEN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 1 | — | 1 | 4 |
| 2021 | 0 | — | 1 | 15 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test intended for use with BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY TORCH Systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. The BIOFIRE BCID2 Panel test is performed directly on blood culture samples identified as positive by a…
Read the full statement (427 words)
The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test intended for use with BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY TORCH Systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. The BIOFIRE BCID2 Panel test is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results.
The following organism types and subtypes are identified using the BIOFIRE BCID2 Panel:
Gram Positive Bacteria
Enterococcus faecalis Staphylococcus spp. Streptococcus spp.
Enterococcus faecium Staphylococcus aureus Streptococcus agalactiae (Group B)
Listeria monocytogenes Staphylococcus epidermidis Streptococcus pneumoniae Staphylococcus lugdunensis
Streptococcus pyogenes (Group A)
Gram Negative Bacteria
Acinetobacter calcoaceticus-baumannii complex Enterobacterales
Bacteroides fragilis Enterobacter cloacae complex
Haemophilus influenzae Escherichia coli
Neisseria meningitidis (encapsulated) Klebsiella aerogenes
Pseudomonas aeruginosa Klebsiella oxytoca
Stenotrophomonas maltophilia Klebsiella pneumoniae group
Proteus spp.
Salmonella spp.
Serratia marcescens
Yeast
Candida albicans Candida krusei Cryptococcus neoformans/gattii
Candida auris Candida parapsilosis
Candida glabrata Candida tropicalis
The BIOFIRE BCID2 Panel contains assays for the detection of genetic determinants associated with resistance to methicillin (mecA/C and mecA/C in conjunction with MREJ), vancomycin (vanA and vanB), ß-lactams including penicillins, cephalosporins, monobactams, and carbapenems (blaCTX-M, blaIMP, blaKPC, blaNDM, blaOXA48-like, blaVIM) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In addition, the panel includes an assay for the detection of the mobilized genetic determinant mcr-1, an emerging marker of public health importance. The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, ß-lactams, and colistin exist.
Antimicrobial Resistance Genes
CTX-M KPC mecA/C NDM vanA/B
IMP mcr-1 mecA/C and MREJ (MRSA) OXA-48-like VIM
The BIOFIRE BCID2 Panel is indicated as an aid in the diagnosis of specific agents of bloodstream infection and results should be used in conjunction with other clinical and laboratory findings. Positive results do not rule out co-infection with organisms not included in the BIOFIRE BCID2 Panel. The BIOFIRE BCID2 Panel is not intended to monitor treatment for bloodstream infection.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not detected by the BIOFIRE BCID2 Panel, and for determination of species detected but not identified within complexes, groups, or genera by the BIOFIRE BCID2 Panel assays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243759 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243759: BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243759
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026